CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01987089
NCT01987089N/ACompleted

The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse

VA Office of Research and Development·interventional·Posted Nov 19, 2013·Updated Aug 7, 2020

In Brief

A clinical study evaluating Cognitive Behavioral Therapy for Insomnia (CBT-I) for Insomnia. Completed, enrolled 63 participants across 1 site.

Detailed Summary

Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been associated with anxiety and depressive symptoms, as well as an increased risk of relapse back to the drinking. Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I may be efficacious for insomnia during recovery. The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if an improvement in the insomnia is associated with an improvement in the underling alcoholism and the daytime functioning. On an exploratory basis, the association of a first-degree family history of alcoholism with the insomnia severity and treatment response will also be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 19, 2013
Enrollment StartAug 15, 2014
Primary CompletionMay 23, 2019
Study CompletionMar 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.6 years ago

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)behavioral

Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.